This application addresses broad Challenge Area (06): Enabling Technologies and specific Challenge Topic: 06-CA-101: Enhancing Electronic Patient-Reported Outcomes Assessment in Clinical Research or Healthcare Delivery. There is a growing recognition of the importance of subjective patient-reported outcomes (PRO) in patient care. Several recent studies have observed positive impacts of routine use of PRO assessments in clinical practice, reporting improved physical, functional and emotional well-being, reduced hospitalization, better detections of less observable and subjective PRO concerns, and better patient-provider communication. Recognizing the value and potential of PRO assessments, the NIH is completing a 5-year $25MM Roadmap Initiative, called the Patient-Reported Outcomes Management Information System (PROMIS), and in the process of funding the second round of PROMIS research activities. The goal of the PROMIS Initiative is to develop and validate a new set of standardized PRO instruments based on modern computerized adaptive testing (CAT) and item response theory (IRT). A primary benefit, amongst many others, of CAT/IRT-based instruments is that they are dynamically administered, tailored to each individual's past responses, and hence much shorter (i.e., fewer items) but without sacrificing measurement precision. Parallel to the PROMIS endeavor, enormous interests exist within both the government and the private industry in developing interoperability standards to facilitate data exchange between heterogeneous healthcare information systems;in particular the government's Health Information Technology (HIT) Initiative that heavily leverages existing industry standards. Standardization efforts for the clinical research community are also in progress;most notably by the Clinical Data Interchange Standards Consortium (CDISC). The promotion of electronic medical records (EMR) system by the Administration as part of the healthcare reform effort furthers the cause of data standardization. Ideally, the vast investment on EMR and data standardization and on PRO-related research such as the PROMIS project should bring the goal of wide adoption of PRO in clinical research and practice closer to fruition. Unfortunately a major gap still exists to prevent this goal from being achieved, namely the lack of data standardization for PRO instruments and assessment results. There has been no concerted effort to bring the PRO community into any data standardization endeavors. This project thus intends to bridge this gap between the PROMIS Initiative and various standardization initiatives so that the benefits of the PROMIS project and the field of outcomes research in general can be fully realized. Specifically, this project seeks to a) establish interoperability data standards for patient-reported outcomes (PRO) instruments and assessment results, including both the conventional static PRO questionnaires and the new adaptive item banks from the NIH PROMIS project;and b) develop interoperability reference implementations of these standards demonstrating integration scenarios with open-sourced electronic medical record (EMR) and clinical trial management (CTM) systems. The impact of this project is highly significant. Data standards are a necessary condition for PRO to be truly adopted and integrated in clinical research and practice. The PROMIS Initiative has already addressed many other barriers inhibiting the adoption of PRO. However, without the data standards, the status quo will still likely persist for years because of the lack of support from EMR/CTM vendors. With the standards, PRO data can become an integral part of clinical data in every EMR/CTM solution and we will then have a real chance to see these great PRO tools in the hands of clinicians and researchers. This project can result in high public health impact with relatively low technical risks. The impact will come from the proposed patient-reported outcomes (PRO)-specific interoperability standards that could help electronic medical record or clinical trial management solution vendors adopt PRO assessments, in particular those adaptive PRO item banks developed by the NIH PROMIS project, into their offerings, finally making PRO available in the hands of clinicians and researchers. Significant efforts have been spent in defining other types of medical data by various standards organizations, providing many technical precedents that can guide our standards development efforts and mitigate technical risks.